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Last Updated: April 21, 2024

Niraparib tosylate - Generic Drug Details


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What are the generic drug sources for niraparib tosylate and what is the scope of patent protection?

Niraparib tosylate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Niraparib tosylate has two hundred and eighty patent family members in fifty-five countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for niraparib tosylate
Generic Entry Dates for niraparib tosylate*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for niraparib tosylate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for niraparib tosylate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ohio State University Comprehensive Cancer CenterPhase 2
Eli Lilly and CompanyPhase 1
National Cancer Institute (NCI)Phase 1

See all niraparib tosylate clinical trials

Pharmacology for niraparib tosylate

US Patents and Regulatory Information for niraparib tosylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-003 Apr 26, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-003 Apr 26, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-002 Apr 26, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-001 Apr 26, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-001 Apr 26, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for niraparib tosylate

Country Patent Number Title Estimated Expiration
Serbia 58936 INDAZOLI SUPSTITUISANI AMIDOM KAO INHIBITORI POLI(ADP-RIBOZA)POLIMERAZE (PARP) (AMIDE SUBSTITUTED INDAZOLES AS POLY(ADP-RIBOSE)POLYMERASE (PARP) INHIBITORS) ⤷  Try a Trial
Australia 2022200520 Niraparib formulations ⤷  Try a Trial
Hong Kong 1131137 AMIDE SUBSTITUTED INDAZOLES AS POLY(ADP-RIBOSE)POLYMERASE (PARP) INHIBITORS ⤷  Try a Trial
Denmark 1684736 ⤷  Try a Trial
Brazil PI0417056 inibidores de reparo de dano no dna para tratamento de cáncer ⤷  Try a Trial
Mexico 2019011496 COMPOSICIONES DE NIRAPARIB. (NIRAPARIB COMPOSITIONS.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for niraparib tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2109608 132018000000263 Italy ⤷  Try a Trial PRODUCT NAME: NIRAPARIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, UN SUO STEREOISOMERO O TAUTOMERO, IN PARTICOLARE IL TOSILATO O UN IDRATO, IN PARTICOLARE IL TOSILATO MONOIDRATO(ZEJULA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1235, 20171120
2240466 18C1020 France ⤷  Try a Trial PRODUCT NAME: LE TOSYLATE DE NIRAPARIB OU L'UN DE SES HYDRATES,EN PARTICULIER LE TOSYLATE DE NIRAPARIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171120
2240466 300938 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
1633724 2015/016 Ireland ⤷  Try a Trial PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724 92680 Luxembourg ⤷  Try a Trial PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218
2109608 122018000048 Germany ⤷  Try a Trial PRODUCT NAME: NIRAPARIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, STEREOISOMER ODER TAUTOMER DAVON, EINSCHLIESSLICH DES TOSYLATS DAVON; REGISTRATION NO/DATE: EU/1/17/1235 20171116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.